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U.S. Department of Health and Human Services

Class 2 Device Recall Keystone PrimaConnex Tapered Implant TC

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  Class 2 Device Recall Keystone PrimaConnex Tapered Implant TC see related information
Date Initiated by Firm March 11, 2013
Date Posting Updated March 20, 2013
Recall Status1 Terminated 3 on September 26, 2013
Recall Number Z-0973-2013
Recall Event ID 64633
510(K)Number K051614  
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm
Catalog Number: l5613K.

Implants in support for fixed bridgework.
Code Information Lot Number: 12857
Recalling Firm/
Keystone Dental Inc
144 Middlesex Tpke
Burlington MA 01803-4403
For Additional Information Contact Jamie Picariello
Manufacturer Reason
for Recall
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
FDA Determined
Cause 2
Packaging process control
Action Keystone Dental initially called customers on 3/11/13 and forms were completed to document these calls. In addition, a letter sent via Federal Express/or hand delivered to all distributors and customers. Product requested to be returned.
Quantity in Commerce 120 units
Distribution Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NDP and Original Applicant = LIFECORE BIOMEDICAL, INC.